K233220
- 510(k) number
- K233220
- Device name
- EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)
- Applicant
- Senorx, Inc. AZ · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2023-10-27
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233220.pdf
Official FDA record: K233220
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.